Core Insights - Clearside Biomedical, Inc. has successfully completed an End-of-Phase 2 meeting with the FDA, aligning on Phase 3 plans for CLS-AX in the treatment of wet AMD [1][3] - The company’s Asia-Pacific partner, Arctic Vision, has had its New Drug Application for ARCATUS accepted for regulatory review in China [1][3] - Multiple presentations at medical meetings have highlighted the advantages of Clearside's suprachoroidal drug delivery system [1][8] Recent Developments - The FDA meeting confirmed key elements of the Phase 3 program for CLS-AX, including trial design and endpoints, based on positive Phase 2b results [3] - Arctic Vision's NDA for ARCATUS has been accepted in China, with previous approvals in Australia and Singapore [3] - Clearside's partners are advancing their suprachoroidal drug candidates into Phase 3 trials, including REGENXBIO and Aura Biosciences [3] Financial Performance - For Q4 2024, Clearside reported license and other revenue of $0.3 million, down from $6.3 million in Q4 2023 [4][5] - R&D expenses for Q4 2024 were $4.2 million, a decrease from $6.3 million in Q4 2023, attributed to lower clinical trial costs [4][5] - The net loss for Q4 2024 was $7.3 million, compared to a net loss of $4.8 million in Q4 2023 [4][5] Company Overview - Clearside Biomedical is focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, utilizing its patented SCS Microinjector [9] - The company is developing a pipeline of small molecule candidates, with its lead program, CLS-AX, targeting wet AMD [9] - Clearside has also developed XIPERE, which is commercially available in the U.S. through a partner [9]

Core Insights - Clearside Biomedical is advancing suprachoroidal drug delivery as a transformative method for treating macular diseases, with six abstracts accepted for presentation at the ARVO 2025 Meeting [1][2] Company Developments - The company’s proprietary formulation, CLS-AX, a suspension of axitinib, shows potential as a long-acting therapy for wet age-related macular degeneration (AMD), demonstrating durability and safety in clinical trials [2][5] - The SCS Microinjector allows for targeted delivery of therapeutics directly to the retina, enhancing the precision and applicability of treatments [1][6] - Clearside is planning a Phase 3 program for CLS-AX and is also evaluating other small molecules for treating geographic atrophy [7] Research and Presentations - Six abstracts related to the suprachoroidal drug delivery platform will be presented at the ARVO 2025 Meeting, covering topics such as the efficacy of CLS-AX and advancements in training models and segmentation algorithms [1][3][4] - Notable presentations include top-line results from the ODYSSEY Phase 2b study and a literature review on the evolving role of suprachoroidal drug delivery [3][4] Technology and Innovation - The SCS injection platform provides unprecedented access to the back of the eye, allowing for a non-surgical procedure that could improve patient outcomes [6][7] - The SCS Microinjector is designed with custom features to optimize drug administration, potentially reducing toxic effects on non-diseased cells [6]

Core Insights - Clearside Biomedical is advancing its lead clinical program, CLS-AX, for the treatment of neovascular age-related macular degeneration (wet AMD) through its unique suprachoroidal delivery platform [2][10] - The company emphasizes the need for more sustainable and less frequent treatment options for wet AMD, highlighting the potential benefits of its innovative delivery method [3][4] Group 1: Clinical Program and Technology - CLS-AX is a proprietary injectable suspension of axitinib, a tyrosine kinase inhibitor (TKI), designed for suprachoroidal injection, which may offer advantages over existing therapies by achieving pan-VEGF blockade [7][8] - Recent clinical trials have shown that CLS-AX is well tolerated and has a positive safety profile, with the potential for prolonged duration and targeted delivery to affected tissue layers [8][9] - The suprachoroidal injection method could reduce the risk of complications such as endophthalmitis and cataract, which are associated with traditional intravitreal therapies [4][5] Group 2: Regulatory and Market Context - The wet AMD market is significant, valued at over $12 billion, and the company is preparing for a Phase 3 clinical trial following successful discussions with the FDA [5][10] - Clearside's regulatory strategies are informed by recent FDA guidance, which will shape the development of CLS-AX and its positioning in the market [5][6] - The company aims to transform treatment options for retinal diseases through its patented SCS Microinjector, which allows for targeted and compartmentalized drug delivery [9][10]

Core Insights - Clearside Biomedical is advancing its lead clinical program, CLS-AX, for the treatment of neovascular age-related macular degeneration (wet AMD) through its innovative suprachoroidal delivery platform [1][6][9] - The company emphasizes the need for more sustainable and less frequent treatment options for wet AMD, highlighting the potential benefits of its suprachoroidal injection method [2][3] Group 1: Clinical Program and Technology - CLS-AX is a proprietary injectable suspension of axitinib, a tyrosine kinase inhibitor (TKI), designed for suprachoroidal injection, which may offer advantages over existing therapies by achieving pan-VEGF blockade [6][7] - Recent clinical trials have shown that CLS-AX is well tolerated and has a positive safety profile, with the potential for prolonged duration and targeted delivery to affected tissues [7][8] - The company is planning a Phase 3 trial for CLS-AX following a successful End-of-Phase 2 meeting with the FDA, indicating a strong regulatory strategy [3][4] Group 2: Market Context and Regulatory Strategy - The wet AMD market is significant, valued at over $12 billion, and there is a growing demand for innovative treatment options that can reduce the treatment burden on patients [4][9] - Clearside's presentations at the 2025 Wet AMD & Diabetic Eye Disease Summit highlighted the limitations of current anti-VEGF therapies and the potential of suprachoroidal delivery to transform treatment [2][3] - The company is actively engaging with the FDA to navigate the regulatory landscape for wet AMD therapies, which will inform its clinical development plans [4][9]

Core Viewpoint - Clearside Biomedical, Inc. is set to report its fourth quarter and full year 2024 financial results on March 27, 2025, followed by a conference call to discuss the results and provide a corporate update [1]. Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on innovative delivery of therapies to the back of the eye through the suprachoroidal space (SCS) [3]. - The company utilizes its patented SCS Microinjector for a non-surgical procedure aimed at delivering various therapies to the macula, retina, or choroid, potentially improving vision in patients with serious eye diseases [3]. - Clearside is developing a pipeline of small molecule product candidates for administration via its SCS Microinjector, with its lead program, CLS-AX, in development for treating neovascular age-related macular degeneration (wet AMD) [3]. - The company has gained approval for its first product, XIPERE, which is available in the U.S. through a commercial partner [3]. - Clearside also partners strategically with other companies to utilize its SCS injection platform alongside other ophthalmic therapeutic innovations [3].

Core Insights - Clearside Biomedical has received positive feedback from the FDA regarding its CLS-AX program for treating wet AMD, indicating a promising path forward for the Phase 3 trials [2][4] - CLS-AX aims to differentiate itself in the $12+ billion wet AMD market through flexible dosing and extended duration compared to existing therapies [2][4] Company Overview - Clearside Biomedical is focused on revolutionizing therapy delivery to the back of the eye using its proprietary suprachoroidal space (SCS) injection platform [7] - The company is developing CLS-AX, an injectable suspension of axitinib, which is a tyrosine kinase inhibitor that targets VEGF receptors to potentially improve treatment outcomes for retinal diseases [4][7] CLS-AX Phase 3 Program - The proposed Phase 3 program includes two pivotal non-inferiority trials with a primary endpoint of average change in best corrected visual acuity (BCVA) at Week 52 [5] - Each trial will involve approximately 225 participants per arm, comparing CLS-AX (1 mg) to aflibercept (2 mg), focusing on treatment-naïve participants to expedite recruitment [5] - The trials are designed to support a flexible maintenance dosing label for CLS-AX, allowing for administration every 3 to 6 months based on physician assessments [2][5] Clinical Development and Safety - CLS-AX has demonstrated a positive safety profile and re-dosing capability in previous clinical trials, indicating its potential as a compelling alternative in the wet AMD market [2][4] - The company plans to conduct a one-year safety follow-up period to meet registration requirements, ensuring comprehensive safety data is available [5] SCS Injection Platform - Clearside's SCS injection platform allows for targeted delivery of therapies to the back of the eye, potentially improving efficacy and reducing toxic effects on non-diseased cells [6][7] - The SCS Microinjector is designed for precise administration of various drug candidates, enhancing the treatment of sight-threatening diseases [6][7]

Core Viewpoint - Clearside Biomedical's partner, Arctic Vision, has had its New Drug Application for ARCATUS® accepted for review in China, supported by positive Phase 3 clinical trial results for treating uveitic macular edema [1][2][3] Company Overview - Clearside Biomedical is a biopharmaceutical company focused on innovative delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) [1][8] - The company has developed a proprietary SCS Microinjector® that allows for targeted delivery of medications, potentially improving efficacy and reducing toxicity [4][8] Product Information - ARCATUS® (known as XIPERE® in the U.S.) is the first approved suprachoroidal therapy for uveitic macular edema, already approved in the U.S., Australia, and Singapore [2][5] - XIPERE® is a triamcinolone acetonide injectable suspension designed for suprachoroidal use, currently available in the U.S. through Bausch + Lomb [5][8] Market Potential - The Chinese uveitis market is significant, with several million patients affected, indicating a large potential customer base for ARCATUS® [3] - The global uveitis treatment market is projected to grow from approximately $2.3 billion in 2023 to $4.5 billion by 2032, highlighting the increasing demand for effective treatments [6][7] Collaboration and Development - Arctic Vision holds exclusive rights for the commercialization and development of XIPERE® in Greater China and other regions, and is collaborating with Santen Pharmaceutical for further development [3][5] - The company is also exploring the use of ARVN001 for other ocular retinal diseases, including diabetic macular edema [3]

ALPHARETTA, Ga., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD) ("Clearside" or the "Company"), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), reported that Arctic Vision's New Drug Application (NDA) for ARCATUS® for the treatment of uveitic macular edema (UME) has been formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration. The NDA subm ...

- BCVA and CST Data from Sub-Group Analyses Provide Key Insights for Planned CLS-AX Phase 3 Trial Design -ALPHARETTA, Ga., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that two subgroup analyses were presented from the ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration ...

ALPHARETTA, Ga., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today George Lasezkay, PharmD, JD, President and Chief Executive Officer, and Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, will participate in a Fireside Chat at the Oppenheimer 35th Annual Healthcare Life Sciences Virtual Conferen ...